1. Field of the Disclosure
The present disclosure generally relates to urinary catheters. More particularly, the present disclosure relates to sleeveless urinary catheter assemblies having a protective tip.
2. Description of Related Art
Catheters are used to treat many different types of medical conditions and typically include an elongated shaft that is inserted into and through a passageway or lumen of the body. Catheters, and in particular intermittent catheters, are commonly used by those who suffer from various abnormalities of the urinary system, such as urinary incontinence. With the advent of intermittent catheters, individuals with urinary system abnormalities can self-insert and self-remove intermittent catheters several times a day. Such catheters typically include a shaft that is sufficiently flexible to navigate the curves of the urethra (especially catheters intended for male users), yet rigid enough to be pushed through the urethra without collapsing or “snaking” before an end of the catheter reaches the bladder.
An exemplary male urinary catheter C according to conventional design is shown in FIG. 1. A proximal end P of the catheter C includes draining holes or eyes E for the drainage of bodily fluids therethrough and into an internal conduit or lumen of the catheter C. The distal end D of the catheter may include a connecting member F, such as a funnel, for fluidly connecting the catheter C to a collection container, such as a collection bag into which urine drains.
The catheter C may be used in combination with a protective tip or cap or cover T (FIG. 2) that substantially encircles at least a portion of the proximal end P. FIG. 3 shows the proximal end P of the catheter C received within the protective tip T. The protective tip T has a generally tubular body portion B defining an interior cavity V (FIG. 3) that extends between an open end O and an access end A. The open end O is the end of the protective tip T into which the catheter C is inserted (in a direction toward the access end A). The access end A is movable between a generally closed condition when the proximal end P of the catheter C is positioned within the protective tip T (illustrated) and a generally open condition when the catheter C is advanced proximally (i.e., in a right-to-left direction in the orientation of FIG. 3) so as to pass through the access end A for advancement into and through the urethra. As shown in FIGS. 2 and 3, the access end A of the protective tip T may include one or more slits S, according to conventional design, that allow it to move between the generally closed and generally open conditions.
The protective tip T serves to isolate the proximal end P of the catheter C (including the eyes E) from the outside environment (e.g., from touch contamination whereby bacteria present on a user's hands might be transferred to the proximal end P of the catheter C) prior to insertion into the urethra and from the relatively high concentration of bacteria typically present in the distal urethra. By isolating the proximal end P of the catheter C from the outside environment, the sterility of the proximal end P may be maintained, thereby preventing bacteria from attaching to the proximal end P and being transferred to the urinary system. As shown in FIG. 3, the outer diameter of the catheter C may be smaller than the inner diameter of the protective tip T, such that there is a generally annular gap separating the catheter C and the protective tip T. Accordingly, to associate the protective tip T to the catheter C, a sleeve or cover (not illustrated) may be used to connect and secure together the protective tip T and the catheter C, thus preventing the protective tip T from detaching from the catheter C.
FIGS. 2A and 3A illustrate another embodiment of a known protective tip T′. As in the embodiment of FIGS. 2 and 3, the protective tip or cap or cover T′ substantially encircles at least a portion of the proximal end P of a catheter C, but does not have a closed access end A. Instead, the protective tip T′ of FIGS. 2A and 3A has a generally tubular body portion B′ defining an interior cavity V′ (FIG. 3A) that extends between a distal open end O′ and a proximal open end G. The distal open end O′ is the end of the protective tip T′ into which the catheter C is inserted (in a direction toward the proximal open end G). Unlike the access end A of FIGS. 2 and 3, the proximal open end G is not movable into a closed condition, but remains open during use. Accordingly, rather than serving to isolate the proximal end P of the catheter C from the outside environment, the protective tip T′ serves as a gripper or gripping member that may be held by a user to manipulate and deploy the catheter C without directly handling the catheter C, and so may be referred to herein as a “gripper-type” protective tip. It should be noted that FIGS. 2 and 2A illustrate only two exemplary embodiments of known protective tips, and there are a number of other differently configured protective tips that are known and may be used in combination with the apparatus and methods described herein.
The present disclosure provides sleeveless urinary catheter assemblies with a protective tip, thereby avoiding the cost associating with manufacturing a sleeve and incorporating it into the catheter design.